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510(k) K905286

IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

Other clearances by Internacional Farmaceutica, S.A. DE C.V.

  • K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES (May 23, 2008)
  • K072859 — ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES (May 23, 2008)
  • K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 4, 2004)
  • K040282 — ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID (April 29, 2004)
  • K913185 — STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT (December 4, 1991)
  • K911354 — STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES (October 25, 1991)
  • K911189 — STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE (April 25, 1991)
  • K905287 — IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES (February 11, 1991)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

Other clearances for product code GAR

  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)
  • K060471 — FSSB NYLON SURGICAL SUTURES (July 26, 2006)